Clinical OMICS

MAY-JUN 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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12 Clinical OMICs May/June 2019 www.clinicalomics.com detect cancer with 90 percent sensitivity." GRAIL is also among those companies developing a pan-cancer EDT. Its prototype cfDNA sequencing assay detects a long list of cancer types: colorectal, lung, esopha- geal, head and neck, liver, ovarian, pancreatic, lymphoma, multiple myeloma, and certain aggressive breast cancers. "Many of these cancer types are not screened for today and often present at late stages," said Kelsey Grossman, a spokes- person for GRAIL. Grossman also said that GRAIL has devel- oped the capability to detect tissue of origin and will present that data at a future medical conference. Optimizing EDT assays involves using bioinformatics and machine learning algorithms on large molecular data sets. Ultimately, GRAIL will collect data from 165,000 peo- ple. Its Circulating Cell-free Genome Atlas (CCGA) study is a prospective, observational, longitudinal study designed to characterize the landscape of genomic cancer signals in the blood of people with and without cancer. The study is fully enrolled with approximately 15,000 participants across 142 sites in the United States and Canada. The company's STRIVE study is fully enrolled with approximately 100,000 women at the time of their screening mammogram and the SUMMIT study will enroll approximately 50,000 men and women age 50 to 77 years who do not have a cancer diagno- sis at the time of enrollment. These large numbers are needed because the fraction of tumor-derived cfDNA in the blood is very small compared to that of normal cells. "An early detection test needs to be backed by a body of evidence involving tens of thousands of participants to distinguish true cancer signals from bio- logical noise and predict the cancer 's tissue of origin when cancer is present to enable doctors to appropriately direct next steps for diagnosis and care," Grossman said. It is important that EDTs have a very low rate of false positive results. "While current screening options are very good at detecting certain cancers, false positive results are frequent, causing people anxiety and many unnecessary follow-up procedures. High false-positive rates often limit the use of screening tests." Seeking cancer While GRAIL and Guardant are working on pan-cancer assays, PapGene is taking a stepwise approach. In 2018, the company was granted Breakthrough Device Des- ignation from the FDA for an EDT that screens for ovarian and pancreatic cancer. Like most EDTs, the assay uses a combination of tumor-derived cfDNA and protein biomarkers to detect cancer in indi- viduals over the age of 65. "This is the first step toward our vision of making pan-cancer detection a reality for patients and dramatically improving cancer survival rates," said PapGene CEO How- ard Kaufman at the time in a statement. The com- pany's test is based on the technology behind CancerSEEK, a pan-cancer EDT developed by researchers at the Johns Hopkins Kimmel Cancer Center. In 2018, the cancer cen- ter 's researchers published a paper in Science describ- ing an EDT that tests for eight common cancer types: ovarian, liver, stom- ach, pancreas, esophagus, colorectal, lung, and breast cancers. Screening tests are currently available for only the three of these cancers: breast, colorectal, and lung. Researchers explored sev- eral hundred genes and 40 protein markers, eventually settling on 16 genes and eight proteins. They also reported that the test, which was evalu- ated on 1005 patients with non-metastatic cancers in stages I to II, had a sensitivity that ranged from 98 percent for ovar- (continued from previous page) (continued on page 14 John Simmons, VP, Personal Genome Diagnostics (PGDx) Johner Images / Getty Images "When we started Guardant, we imagined that some day patients would go through cancer screening at their annual check-ups." —Amirili Talasaz COO, Guardant Health

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